Spinal Cord Stimulation for Parkinson's Disease

(SCS for FOG Trial)

Recruiting at 1 trial location

Overseen By Rory Mahabir

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nora Vanegas-Arroyave

Must be taking: Dopaminergic medications

Must not be taking: Anticoagulants

Disqualifiers: Psychosis, Depression, Anxiety, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 months

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if spinal cord stimulation (SCS) can assist people with Parkinson's disease who experience freezing of gait (FOG), a symptom where walking suddenly becomes impossible. FOG can be frustrating and doesn't always improve with standard medications or surgery. Researchers are testing two methods of using SCS to identify which is most effective in easing FOG and enhancing quality of life. Individuals with Parkinson's who frequently experience FOG episodes that standard treatments haven't alleviated might be suitable candidates for this study. As an unphased study, this trial offers participants a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that patients on anticoagulation treatment must stop these medications 7 days before the procedure. It seems you can continue other Parkinson's treatments like dopaminergic medications or deep brain stimulation.

What prior data suggests that spinal cord stimulation is safe for Parkinson's disease patients?

Research has shown that spinal cord stimulation (SCS) has successfully managed long-term pain for over 10 years. This history suggests that SCS is generally safe and well-tolerated. In studies, patients received SCS devices after a successful trial period, experiencing significant pain relief without major side effects.

While SCS is mainly used for chronic pain, its safety in these cases offers reassurance for its use in treating walking difficulties in Parkinson's disease. However, safety can vary based on individual health conditions, so discussing potential risks with a healthcare provider is recommended before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using spinal cord stimulation (SCS) for Parkinson's disease because it offers a novel approach to managing symptoms. Unlike current treatments that mainly rely on medication to boost dopamine levels, SCS targets the nervous system directly. The trial explores two unique methods: burst stimulation and tonic stimulation. Burst stimulation mimics natural nerve firing patterns, potentially reducing side effects, while tonic stimulation provides continuous electrical impulses. These distinctive approaches could offer more consistent symptom relief and improve the quality of life for patients with Parkinson's disease.

What evidence suggests that spinal cord stimulation is effective for freezing of gait in Parkinson's disease?

Research has shown that spinal cord stimulation (SCS) might alleviate symptoms of Parkinson's disease, particularly freezing of gait (FOG). FOG occurs when a person suddenly cannot move for a short time. Clinical findings are promising, as SCS has benefited individuals with FOG who do not respond to standard treatments. This trial will compare two types of SCS: Burst stimulation and Tonic stimulation. Studies with animals and some human data suggest that SCS can reduce FOG episodes and improve overall mobility. While further research is necessary, SCS is considered a hopeful option for managing FOG in individuals with Parkinson's disease. ^{2 3 5 6 7}

Who Is on the Research Team?

Nora Vanegas, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Parkinson's Disease who have optimized their treatment but still experience at least two episodes of freezing gait daily that don't improve with medication. They must meet specific criteria for PD diagnosis and be able to consent. Excluded are those with certain psychiatric illnesses, uncontrolled medical conditions, or on anticoagulants they can't stop before the procedure.

Inclusion Criteria

I experienced freezing while moving, even after taking my regular Levodopa dose.

Documented dopaminergic response

I am receiving the best possible treatment for Parkinson's, including medications or DBS.

Exclusion Criteria

I am on blood thinners and cannot stop them for 7 days before a procedure.

I do not have severe mental health issues that could affect my study participation.

I have severe, ongoing pain in my back or leg after surgery, or I have CRPS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spinal cord stimulation (SCS) with either burst or tonic stimulation to assess effects on freezing of gait (FOG) in Parkinson's Disease

12 months

Regular visits for SCS programming and monitoring

Follow-up

Participants are monitored for safety, tolerability, and effectiveness of SCS on FOG, including assessments using PDQ-39, NMSS, NFOG-Q, and other measures

12 months

Periodic assessments over 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Cord Stimulator (SCS)

Trial Overview The study tests if spinal cord stimulation (SCS) can reduce episodes of freezing gait in Parkinson's patients when standard treatments fail. It will compare two SCS programming methods to see how they affect motor skills, nonmotor symptoms, and life quality.

How Is the Trial Designed?

Group I: Spinal Cord Stimulation (SCS) Tonic stimulation Experimental Treatment 1 Intervention

Tonic stimulation

Group II: Spinal Cord Stimulation (SCS) Burst stimulation Experimental Treatment 1 Intervention

Burst stimulation.

Spinal Cord Stimulator (SCS) is already approved in United States, European Union for the following indications:

Approved in United States as Nevro HF10 Spinal Cord Stimulation Therapy for:

• Chronic intractable pain of the trunk and/or limbs
• Failed back surgery syndrome
• Intractable low back pain
• Leg pain
• Painful diabetic neuropathy

Approved in European Union as Nevro HF10 Spinal Cord Stimulation Therapy for:

• Chronic intractable pain of the trunk and/or limbs
• Failed back surgery syndrome
• Intractable low back pain
• Leg pain
• Painful diabetic neuropathy

Who Is Running the Clinical Trial?

Nora Vanegas-Arroyave

Lead Sponsor

Trials

1

Recruited

10+

Nora Vanegas

Lead Sponsor

Trials

2

Recruited

20+

Published Research Related to This Trial

Spinal cord stimulation (SCS) showed a significant reduction in motor symptoms for Parkinson's disease patients, with an average decrease of 4.43 points on the Unified Parkinson Disease Rating Scale-III (UPDRS-III), indicating a 14% improvement.

SCS also effectively reduced pain, with a 59% decrease in Visual Analogue Scale (VAS) scores for back and leg pain, suggesting it may provide substantial pain relief in addition to motor benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation for Parkinson's Disease: A Systematic Review and Meta-Analysis of Pain and Motor Outcomes. Sarica, C., Zemmar, A., Yousefi, O., et al.[2023]

Spinal cord stimulation (SCS) significantly reduced pain in Parkinson's Disease patients, with an average reduction of 59% in Visual Analogue Scale (VAS) scores across 15 participants, and up to 67% for those using cycling burst stimulation.

SCS also improved motor symptoms, with 73% of patients showing better performance in a 10-meter walking test and 64% experiencing clinically relevant improvements in the Timed Up and Go (TUG) test, indicating its potential as a treatment option for both pain and motor issues in Parkinson's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single arm prospective multicenter case series on the use of burst stimulation to improve pain and motor symptoms in Parkinson's disease. Chakravarthy, KV., Chaturvedi, R., Agari, T., et al.[2022]

A patient experienced neurological complications, including tinnitus, vertigo, and facial twitches, after receiving a high-frequency spinal cord stimulator, which resolved upon deactivation of the device.

This case highlights the need for further research into the less common neurological side effects of spinal cord stimulation therapy, as current knowledge primarily focuses on surgical site infections and hardware issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Onset Tinnitus after High-Frequency Spinal Cord Stimulator Implantation. Golovlev, AV., Hillegass, MG.[2020]

In a study of 256 patients with chronic intractable pain, 73% reported successful trials with high frequency spinal cord stimulation (HF10 therapy), particularly those with back and leg pain, showing its effectiveness as a treatment option.

Patients experienced a sustained mean pain reduction of 50% up to 6 months post-implant, with significant improvements in functional outcomes, making HF10 a promising alternative to traditional spinal cord stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Chronic Pain: 6-Month Australian Clinical Experience. Russo, M., Verrills, P., Mitchell, B., et al.[2019]

Spinal cord stimulation (SCS) is a safe and effective surgical treatment for chronic neuropathic pain, particularly beneficial for patients with Parkinson's disease.

Tonic SCS has been shown to improve gait disorders, motor symptoms, and overall quality of life in Parkinson's patients, even those who do not respond to dopamine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tonic spinal cord stimulation as therapeutic option in Parkinson disease with axial symptoms: Effects on walking and quality of life. Hubsch, C., D'Hardemare, V., Ben Maacha, M., et al.[2020]

HF10 spinal cord stimulation (SCS) therapy provides effective pain relief for chronic back and leg pain without causing paresthesia, making it a unique option for patients.

Clinical trials and reports indicate that HF10 SCS is safe and effective, even for patients who have not found relief with other neuromodulation therapies, suggesting it could be an important early treatment for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

10-kHz High-Frequency SCS Therapy: A Clinical Summary. Russo, M., Van Buyten, JP.[2022]

The HF10 spinal cord stimulator (SCS) is as effective as traditional low-frequency SCS for treating back and leg pain, with some studies indicating it may provide superior long-term relief.

The HF10 SCS system has a comparable safety profile to traditional SCS and simplifies the implantation process by eliminating the need for intraoperative paresthesia mapping, enhancing patient experience and reducing surgery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the Senza System: a novel, high frequency 10 kHz (HF10), paresthesia free spinal cord stimulator. Ghosh, PE., Simopolous, TT.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32808874/

Overview of HF10 spinal cord stimulation for the treatment ... Overview of HF10 spinal cord stimulation for the treatment of chronic pain and an introduction to the Senza Omnia™ system. Pain Manag. 2020 Nov;10(6):367-376 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715925006919

Technical and Clinical Overview: Spinal Cord Stimulation Spinal cord stimulation (SCS) has evolved from simple systems with limited waveforms and electrode configurations to modern, complex systems ...

3. nevro.com nevro.com/providers/hfx-meaningful-evidence/

HFX Meaningful Evidence - USA - Nevro Sustained effectiveness of 10 kHz high-frequency spinal cord stimulation for patients with chronic, low back pain: 24-month results of a prospective multicenter ...

4. nevro.com nevro.com/en/outcomes/

Outcomes - International English - Nevro Novel 10 kHz High-frequency Therapy (hf10 Therapy) Is Superior To Traditional Low-frequency Spinal Cord Stimulation For The Treatment Of Chronic Back And Leg ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4282782/

Sustained Effectiveness of 10 kHz High-Frequency Spinal ... In patients with chronic low back pain, HF10 SCS resulted in clinically significant and sustained back and leg pain relief, functional and sleep improvements.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/P130022S039B.pdf

P130022S039 Summary of Safety and Effectivness (SSED) The Senza®, Senza II™ and Senza Omnia™ neuromodulation systems are indicated as aids in the management of chronic intractable pain of the trunk and/or limbs, ...

7. nevrohfx.com nevrohfx.com/resources/safety-information/

Important safety information - Nevro HFX For more than 10 years, the Nevro HFX Spinal Cord Stimulation* system has been a safe and effective approach to managing chronic pain.